Join a Clinical Trial

Yes. You can choose not to participate in a clinical trial at Children’s.

You may also choose for your child to be removed from a trial at any time. However, it’s important to consider whether your child should begin a clinical trial. A study can be seriously impacted by parents who change their minds in the middle of treatment and decide to have their child removed from the trial.

Your decision about whether to participate in a study will not affect how the healthcare team feels about you or your child. Your child will still receive the same quality of care.

New trials are developed by a team of doctors, nurses and others with expertise in treating a particular disease. Some trials are organized and conducted at the local and institutional levels, while others are created and administered nationally.

The clinical trial team creates a new plan for how children should be treated for a particular disease. They use information from past clinical trials to develop a new plan that they hope will further improve a child’s health. Each trial is reviewed by many experts before it begins.

Children’s reviews all available clinical trials and chooses to participate in studies that provide the best treatment options for our patients. Before we offer a clinical trial, it must be approved by both the Children’s and Emory University Institutional Review Boards (IRBs). An IRB is a committee that reviews every new clinical trial to help make sure it can be conducted safely and that the trial protects the interests and rights of every patient. The Children’s IRB includes doctors, nurses, psychologists, statisticians and other experts.

Every clinical trial has criteria that participants must meet before they can take part in a study. Talk to your child’s doctor to find out if he is eligible for an active clinical trial.

Your child’s doctor will consider:

• The type and stage of the disease
• Preexisting conditions affecting your child
• Potential side effects of the treatment

Children’s has many clinical research studies that are currently enrolling patients. Our doctors and nurses can help you gather the information you need to locate a study that’s right for your child.

Find a Children’s clinical trial by visiting clinicaltrials.gov. Search for “Children’s Healthcare of Atlanta” and your child’s condition.

Search clinical trials at Emory University

Sometimes, it’s hard to notice a difference. The people, setting and treatments may be the same, but the purpose is different. Research helps find a treatment for a large number of people with a certain condition and also helps answer questions that will affect the future of people with this condition. Standard care focuses on an individual’s needs.

Research can have risks, but there are many people who review a study in detail before any children are enrolled. Most research studies go through multiple stages of testing before the procedure or medicine can be used on children.

At Children’s Healthcare of Atlanta, our Institutional Review Board (IRB) must review and approve a research study before it can start. The IRB makes sure children’s rights and welfare are protected. The board includes doctors, nurses, psychologists and statisticians, among others, who help make sure research is done the right way.

Researchers at Children’s also follow clearly defined government rules for protecting patients enrolled in research, including special protections for children.

At Children’s, we want to provide your child with the best possible medical care. New clinical trials build on the results of past trials, treatments and information learned about a disease. A clinical trial may also allow us to provide more advanced care.

When your child is treated in a clinical trial, he receives some of the most up-to-date treatment available.

During the trial, doctors, nurses and researchers observe your child and look for:

• How well the treatment works
• How it affects healthy cells in the body over time
• How other children in the future might benefit from the treatment—just as your child has been helped from clinical trials of the past

In some instances, your child may not receive a direct benefit from the trial, but your child may provide information that can help improve care for children with the same disease in the future.

Clinical trials are developed in a series of three steps called phases:

• Phase I: A new drug or treatment is tested in a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
• Phase II: The drug or treatment is given to a larger group of people to see if it’s effective and to further evaluate its safety.
• Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.

We encourage you to talk with your child, your Children’s doctor and your family members before deciding to take part.

We recommend you ask the following questions:

• Which treatment do you advise and why?
• What is the chance the treatment will work?
• How will we know if the treatment works?
• What are the known risks of the treatment?
• How long will the treatment last?
• How much will the treatment cost, and who will pay for it?
• How can I help prepare my child for the treatment?
• What alternatives are available for my child?

Researchers will explain the study to you and your child and answer any questions you may have. As part of this process, called “informed consent,” you may also be asked to read and sign a consent form that describes:

• The purpose of the study
• Procedures, risks and benefits
• Alternatives to participating
• Cost of taking part in the study
• Whom to contact with questions or problems

During the study, researchers will review the information learned from the study. They will tell you if they find that it’s not safe for your child to continue in the study. If this happens, your child will be taken out of the study immediately.

You can take your child out of the research study at any time. If you decide to remove your child from the study, it will not affect your ability to access standard care for your child in any way.

Research studies are the building blocks that lead to medical breakthroughs and cures. New studies build on the results of past research studies and current treatments. Most clinical trials use adults, and the resulting products or techniques aren’t designed to meet the unique needs of children.

Clinical research with children allows us to tailor our treatments for them. For example, research can help us find treatments for conditions that only affect kids or find ways to make medicine easier for them to take.

While most studies aren’t conducted solely to help an individual child, there are still benefits to participating in research. If your child participates, he can have access to new treatments and increased monitoring or testing for his disease and can potentially help future generations.